Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients

Inclusion Criteria

• •Patients with cancer, with the exception of patients with active acute leukemia and allogeneic hematopoietic stem cell transplant recipients. Patients may be on active therapy or received therapy (e.g., chemotherapy, radiation or surgery) within 7 years. Patients with active cancer who have not yet been treated (e.g. newly diagnosed cancer or early stage myelodysplastic syndrome \[MDS\] or chronic lymphocytic leukemia \[CLL\]) are eligible. Basal cell cancer and carcinoma in situ treated with local excision alone do not qualify for inclusion
• •Presence of symptomatic infection, defined by fever (temperature \[T\] \>= 38 degrees Celsius \[C\]) OR respiratory symptoms (cough, nasal congestion, or shortness of breath) OR lung infilitrates on chest X-ray or CT imaging. Diagnosis of COVID-19 is based on polymerase chain reaction (PCR) testing of respiratory samples.
• •Age equal to \>= 18 years or older (children are excluded because COVID-19 typically has a milder course in children, and lack of safety data of this regimen in children)
• •Platelet \>= 75,000/uL
• •Hemoglobin \>= 9 g/dL
• •Hematocrit \>= 27%
• •Absolute neutrophil count (ANC) \>= 1000/uL
• •Creatinine clearance \>= 50 mL/min (Cockcroft-Gault Equation-note: plasma creatine instead of serum is used at Roswell Park)
• •Total bilirubin =\< 2 X institutional upper limit of normal (ULN)
• •Aspartate transaminase (AST) (plasma) and alanine transferase (ALT) (plasma) =\< 2 X institutional ULN
• •Plasma amylase and lipase =\< 2 X institutional ULN
• •In the absence of COVID-19, a life expectancy of 6 months is expected
• •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
• •NOTE: For blood chemistry labs, Roswell Park clinical blood chemistries are performed on plasma unless otherwise indicated
• •EXPANSION COHORT: Patients with cancer or allogeneic stem cell transplant recipients with and without a cancer diagnosis
• •* Patients with cancer may be on active therapy or received therapy (e.g., chemotherapy, radiation or surgery) within 7 years
• •* Patients with active cancer who have not yet been treated (e.g. newly diagnosed cancer or early stage MDS or CLL) are eligible
• •* Basal cell cancer and carcinoma in situ treated with local excision alone do not qualify for inclusion
• •Presence of symptomatic infection, defined by fever (T \>= 38.0 degrees C ) OR respiratory symptoms (cough, nasal congestion, or shortness of breath) OR lung infiltrates by chest X-ray or CT imaging. Diagnosis of COVID-19 is based on PCR testing of respiratory samples. Severe infection is excluded
• •Age equal to \>= 18 years or older (children are excluded because COVID-19 typically has a milder course in children, and lack of safety data of this regimen in children). In the absence of COVID-19, a life expectancy of 6 months is expected
• •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. There may be specific instances when the patient can't provide informed consent, e.g. they require mechanical ventilation and are sedated, in which case a health care proxy will be able to provide informed consent. Patients with temporary cognitive impairment will be consented once their capacity has returned. Patients with chronic cognitive impairment, e.g. dementia, that precludes informed consent will not be enrolled.